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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
510(k) Number K923555
Device Name CODMAN GAAB NEUROENDOSCOPE
Applicant
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Applicant Contact NANCY ADELSTEIN
Correspondent
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Correspondent Contact NANCY ADELSTEIN
Regulation Number866.3740
Classification Product Code
GWB  
Date Received07/17/1992
Decision Date 03/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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